Exercise to Improve Outcomes of Treatment for Methamphetamine Users
This study is currently recruiting participants.
Verified March 2010 by University of California, Los Angeles
Sponsor:
University of California, Los Angeles
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01103531
First received: March 31, 2010
Last updated: April 13, 2010
Last verified: March 2010
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Purpose
The purpose of this study is to assess the effects of an aerobic and strength training exercise program (one that increases the need for oxygen and increases muscle) on the treatment outcomes of 150 individuals in treatment for methamphetamine dependence at Cri-Help. The study will determine if a 60-minute exercise program (three times a week) has an effect (good or bad) on the health and drug use of participants as compared to individuals not participating in an exercise program.
| Condition | Intervention |
|---|---|
|
Addictive |
Behavioral: Aerobic and Resistance Exercise Behavioral: Educational information about health topics |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aerobic Exercise to Improve Outcomes of Treatment for Methamphetamine Dependence |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Self-reported Days of Methamphetamine Use [ Time Frame: over the 12 week follow-up period ] [ Designated as safety issue: No ]The primary efficacy measure will be days of self-reported MA use over the 12 weeks after discharge.
Secondary Outcome Measures:
- Overall Physical Health [ Time Frame: 12-week follow-up period ] [ Designated as safety issue: No ]The effect of the interventions will be compared between the Exercise and Education groups using generalized regression for repeated measures on each of the test results from baseline to discharge to 12 weeks post-discharge
- Brain-Imaging Data [ Time Frame: End of intervention (9 weeks) ] [ Designated as safety issue: No ]To examine pre- to post-intervention differences in D2/D3 receptor availability a repeated-measures ANOVA will be performed using the binding potential for [18F]fallypride in subcortical regions of interest.
- Psychiatric Symptoms [ Time Frame: 12 week follow-up period ] [ Designated as safety issue: No ]The effect of the interventions will be compared with repeated measures analysis from baseline to discharge to 12 and 26 weeks after discharge.
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Exercise Group
Participants in this group will be scheduled for 24 exercise training sessions over an 8-week period (three times weekly) and will be supervised by a certified exercise physiologist.
|
Behavioral: Aerobic and Resistance Exercise
Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).
|
|
Active Comparator: Education Group
Participants in this group will meet with a counselor who will present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
|
Behavioral: Educational information about health topics
A counselor will meet with participants for 24 sessions (3 times/week) over an 8-week period to present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be seeking treatment for their MA dependence;
- Be 18 years of age or older, and 45 or younger for males, 55 or younger for females;
- Meet DSM-IV-TR criteria for MA dependence;
- Have vital signs that are within clinically acceptable normal range, e.g., resting pulse between 50 and 90 /min, blood pressures between 85-150mm Hg systolic and 45-90mm Hg diastolic;
- Have a medical history and physical examination that, in the judgment of the study physician or Principal Investigator, show no clinically significant contraindications for study participation;
- For females, provide negative pregnancy urine tests before randomization (and for the sub-sample, another negative test before the final PET scan at the conclusion of the intervention).
Exclusion Criteria:
- Clinically significant heart disease or hypertension; unstable pulmonary or cardiovascular disease that would interfere with participation in exercise regimen
- Neurological or psychiatric disorders as assessed by MINI or clinical interview, such as psychosis, bipolar illness, Tourette's syndrome, major depression, organic brain disease, dementia, or any other neuro-psychiatric disorder that would require ongoing treatment or that would make study compliance difficult;
- Musculoskeletal disease that would prevent participation in exercise regimen
- Baseline ECG showing evidence of cardiac ischemia, arrhythmia, or other clinically significant abnormalities
- Untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease (other than HIV) that requires immediate medical attention;
- Clinically significant abnormalities in hematology and chemistry laboratory tests that may make participation hazardous;
- Have HIV and unable to obtain a clearance for participation from his/her AIDS medical care provider;
- Pregnant;
- Any other illness, condition, or use of medications that, in the opinion of the PI and/or the study physician, would preclude safe participation or completion of the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103531
Contacts
| Contact: Joy Chudzynski, PsyD | 818-255-7022 | joychud@ucla.edu |
Locations
| United States, California | |
| Cri-Help, Inc | Recruiting |
| North Hollywood, California, United States, 91601 | |
| Principal Investigator: Richard Rawson, PhD | |
Sponsors and Collaborators
University of California, Los Angeles
Investigators
| Principal Investigator: | Richard Rawson, PhD | UCLA Integrated Substance Abuse Programs |
More Information
Publications:
| Responsible Party: | Richard Rawson, PhD/Professor and Associate Director, UCLA Integrated Substance Abuse Programs |
| ClinicalTrials.gov Identifier: | NCT01103531 History of Changes |
| Other Study ID Numbers: | 09-08-099, 1R01DA027633 |
| Study First Received: | March 31, 2010 |
| Last Updated: | April 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
Methamphetamine Methamphetamine Dependence Methamphetamine Treatment Aerobic Exercise |
Resistance Exercise Brain Imaging D2 and D3 receptor availability |
Additional relevant MeSH terms:
|
Methamphetamine Amphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013